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Deep Repetitive Transcranial Magnetic Stimulation for Alcohol Use Disorder

Primary Purpose

Alcohol Abuse

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Active dTMS
Sham dTMS
Sponsored by
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 - 65
  • Current diagnosis of alcohol dependence
  • Alcohol use in the past month
  • Right handed (self-report)
  • If female, negative urine pregnancy test
  • If female, must either agree to practice an effective birth control method; agree to abstinence from intercourse; be surgically sterile or postmenopausal for at least one year

Exclusion Criteria:

  • Currently pregnant or breastfeeding
  • More than mild cognitive impairment, as determined by a score on the Montreal cognitive assessment (MoCA) <25.
  • Current diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder
  • Use in the past 2 weeks of medication or illicit drug with known high pro-convulsant action, as self-reported, or detected using urine toxicology screening; and with accordance to the Physician best Judgment.
  • Any history of clinically significant neurological disorders, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes (self-reported history).
  • Any history of seizures other than febrile childhood seizures (self-reported history)
  • Clinically significant hearing impairment
  • Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces). Eligibility will be determined by the "MRI Safety Screening Questionnaire" and verified, if necessary, by a radiology consultant. Some of the patients that will be excluded from the imaging part of the study will be included in the clinical part.
  • Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the investigators and after any consults if indicated, participation in the study is not in the best interest of the patient.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    study group

    control group

    Arm Description

    alcoholics - dTMS group

    alcoholics - sham group

    Outcomes

    Primary Outcome Measures

    Alcohol usage
    The percentage of heavy drinking days (pHDD; 4+ alcohol units per women and 5+ for men, within one day) between the active and sham groups over the follow up period.

    Secondary Outcome Measures

    Alcohol craving
    The scores of the Penn alcohol craving scale (PACS) between the active and sham groups over the follow up period. The PACS is a 5-item questionnaire that measures the individual's alcohol craving in the past week, with each item scored on a scale between 0 and 6 (i.e., minimum value of 0 and maximum value of 30) and higher scores denote higher levels of craving.

    Full Information

    First Posted
    February 7, 2016
    Last Updated
    December 27, 2020
    Sponsor
    Soroka University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02691390
    Brief Title
    Deep Repetitive Transcranial Magnetic Stimulation for Alcohol Use Disorder
    Official Title
    Exploration of the Potential Role of Anterior Cingulate (ACC) dTMS in Relapse to Alcohol Use
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2019 (Actual)
    Study Completion Date
    December 1, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Soroka University Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    dTMS intervention to reduce recurrent alcohol abuse among alcohol users who are abstinent for at least 5 days.
    Detailed Description
    Phase 1: (up to 2 weeks), participants undergo a set of baseline assessments, including questionnaires, rating scales, and resting state functional magnetic resonance imaging (rsfMRI). Phase 2, patients receive one of two treatments: High-frequency (10Hz, 100 trains of 3 sec with 15 sec inter train interval) dTMS targeting the ACC or sham stimulation for 30 min. Each treatment is preceded by provocation (pouring, holding and smelling the subject's favorite alcoholic beverage) designed to activate the relevant brain circuitry (provocation of symptoms may increase response rate to Deep TMS as was evident in the treatment of PTSD, cigarette smoking and OCD). dTMS sessions are conducted five times per week for 3 weeks, for a total of 15 sessions. A second scan that include rsfMRI and a risk-related decision-making task is conducted at the end of this phase. Phase 3 includes 12 weeks of patients' follow-up, including clinical visits at weeks 1, 2, 4, 8 and 12 post treatment. During this phase, subjective and objective measures of alcohol use (self-report and analysis of urine samples for levels of ethyl glucuronide (EtG) and ethyl sulfate (EtS), respectively) are collected. Following completion of the main part by the individual, an "open label" treatment using the same parameters of the experiment is offer (regardless of treatment group).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Abuse

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    51 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Experimental
    Arm Description
    alcoholics - dTMS group
    Arm Title
    control group
    Arm Type
    Sham Comparator
    Arm Description
    alcoholics - sham group
    Intervention Type
    Device
    Intervention Name(s)
    Active dTMS
    Intervention Description
    dTMS to ACC
    Intervention Type
    Device
    Intervention Name(s)
    Sham dTMS
    Intervention Description
    SHAM - no stimulation
    Primary Outcome Measure Information:
    Title
    Alcohol usage
    Description
    The percentage of heavy drinking days (pHDD; 4+ alcohol units per women and 5+ for men, within one day) between the active and sham groups over the follow up period.
    Time Frame
    12 weeks post treatment
    Secondary Outcome Measure Information:
    Title
    Alcohol craving
    Description
    The scores of the Penn alcohol craving scale (PACS) between the active and sham groups over the follow up period. The PACS is a 5-item questionnaire that measures the individual's alcohol craving in the past week, with each item scored on a scale between 0 and 6 (i.e., minimum value of 0 and maximum value of 30) and higher scores denote higher levels of craving.
    Time Frame
    12 weeks post treatment
    Other Pre-specified Outcome Measures:
    Title
    Modifications to brain volume
    Description
    Changes to volumes (cm3) of brain areas that are implicated in alcohol abuse pathophysiology, as measured by MRI from pre- to post-treatment between the active and sham groups.
    Time Frame
    3 weeks of treatment
    Title
    Modifications to functional connectivity
    Description
    Changes to functional connectivity (correlation coefficient) of networks that are implicated in alcohol abuse pathophysiology, as measured by resting state fMRI from pre- to post-treatment between the active and sham groups
    Time Frame
    3 weeks of treatment
    Title
    Modifications to blood-oxygen-level-dependent (BOLD) signal
    Description
    Changes to blood-oxygen-level-dependent (BOLD) signal (arbitrary units) of brain areas that are implicated in alcohol abuse pathophysiology during behavioral tasks, as measured by fMRI following treatment between the active and sham groups.
    Time Frame
    3 weeks of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 - 65 Current diagnosis of alcohol dependence Alcohol use in the past month Right handed (self-report) If female, negative urine pregnancy test If female, must either agree to practice an effective birth control method; agree to abstinence from intercourse; be surgically sterile or postmenopausal for at least one year Exclusion Criteria: Currently pregnant or breastfeeding More than mild cognitive impairment, as determined by a score on the Montreal cognitive assessment (MoCA) <25. Current diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder Use in the past 2 weeks of medication or illicit drug with known high pro-convulsant action, as self-reported, or detected using urine toxicology screening; and with accordance to the Physician best Judgment. Any history of clinically significant neurological disorders, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes (self-reported history). Any history of seizures other than febrile childhood seizures (self-reported history) Clinically significant hearing impairment Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces). Eligibility will be determined by the "MRI Safety Screening Questionnaire" and verified, if necessary, by a radiology consultant. Some of the patients that will be excluded from the imaging part of the study will be included in the clinical part. Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the investigators and after any consults if indicated, participation in the study is not in the best interest of the patient.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Deep Repetitive Transcranial Magnetic Stimulation for Alcohol Use Disorder

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